Women sue for breast cancer

Twenty Britons are suing after developing a rare form of cancer related to their breast implants.

More than 50 women have been diagnosed with the same condition in the UK and hundreds of others in the world.

A senior surgeon said that there were gaps in information about implants and that people were almost "used as guinea pigs".

A manufacturer has published a worldwide reminder of some textured implants, which have been associated with most lymphomas associated with breast implants.

The MHRA, the regulatory agency for medicines and health products, which regulates medical devices in the UK, is currently collecting data on women with large-cell anaplastic lymphoma associated with implants mammals (BIA-ALCL).

He evaluated the risk for one implant out of 24,000 sold (by examining both textured implants and other types of breast implants).

It is thought that tens of thousands of breast implant surgeries take place each year in the UK, mostly in private clinics.

"I was afraid to die"

Linzy Bromfield, 50, is one of the women who is taking legal action – in her case against the manufacturer.

After having two children, she privately paid for breast augmentation in 2005 and switched from cup bra D to cup D.

Linzy was very pleased with her implants, but 13 years later in 2016, she noticed that her right breast had become so swollen that she was unable to wear her bra.

She had a drained breast fluid in an NHS hospital and was then diagnosed with an implant-associated lymphoma.

"I cried, really cried.I was angry and hurt.I could not really understand it at first.I was afraid to die.

"I think when you hear that word 'cancer', do you think I'm going to die?"

Linzy has had both implants removed and has been free of disease since. However, other women needed additional treatment, including chemotherapy.

What is a lymphoma associated with an implant?

It is a cancer of the immune system, not a type of breast cancer, and it is a rare subtype of non-Hodgkin's T cell lymphoma.

Nigel Mercer, plastic surgeon and chair of an advisory group of surgeons monitoring cancer cases on behalf of the MHRA, said, "The same type of implant has been around for 30 years, but we do not have it. We have seen that recently, as a disease, it looks like it's a really new disease. "

Generally, cancer cells are found near scar tissue and fluid near the implant but, in rare cases, they can spread.

If caught early, the lymphoma can be cured by removing the implant and the capsule that surrounds it.

Cases occurred between three and 14 years after surgery.

Doctors do not know how BIA-ALCL is provoked – but scientists think that it could be a reaction to the textured surface of the implant or an infection bacterial.

What do surgeons say?

Linzy's surgeon, Professor James Frame, who works in Chelmsford, Essex, said he was shocked by his case, the only one he saw among the 30,000 surgeries breast or more than he has performed.

He says that there is not enough information available to surgeons about the potential risks associated with different breast implants.

"It takes a more robust information package for those who provide the service. [UK research around this] is terrible, "he said.

Prof Frame believes that insurance packages could be made available to patients opting for private surgery to ensure they receive long-term care.

Mr. Mercer says that there are many unknowns regarding breast implants and that doctors have a moral duty to tell the patients.

He stated that British women were not "appropriately warned that breast implants are not necessarily for life".

"There are unknowns with any implant, but that means we use almost our entire population as human guinea pigs, or almost."

Dr. Mercer and Prof Frame both call for international collaboration among clinicians around the world to share breast implant data.

What is the advice to women?

The MHRA issued a joint statement with several of the largest surgeon associations in the UK in July. It is "essential" for surgeons to ensure that all patients who are considering a breast implant for reconstructive or cosmetic purposes are fully aware of the potential risks.

The organization also claims that breast implants undergo a rigorous risk-based approval process before being used by the general population.

Women who have textured implants may not need to have them removed, but should consult their clinician if they have any concerns or symptoms.

Unnecessary removal of implants may result in a risk of additional surgical complications.

And then?

When Linzy had his implants laid in 2005, BIA-ALCL was not widely known and neither the surgeons nor the patients had been informed of the risks.

Linzy says she may have had the surgery anyway, but thinks some women might be put off in the future.

Women sue surgeons and manufacturers. They want to recover the costs of implants and their removal, as well as bodily injury, distress and any potential financial loss. Letters before action are sent to affected parties this month.

Their lawyer, Zahra Nanji, of Leigh Day, said, "I am really convinced that manufacturers, producers and distributors of these implants must shoulder their responsibilities."

Manufacturer Allergan stated that patient safety was a priority and that she would support informative labeling "to promote and promote the safest use of breast implant products".

"We continue to invest and support work to strengthen BIA-ALCL's understanding and increase brand awareness," the company said.

She published a worldwide voluntary reminder of textured breast implants and tissue expander filled with Biocell saline and silicone.

---